Research on Optimal Strategy of Hypoglycemic Therapy for Cirrhosis With Diabetes

NCT05641337 | Unknown Phase 3

• 1 other identifier: 2022-10-cirrhosis with DM
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

Poor blood glucose control in liver cirrhosis can aggravate the poor prognosis of patients. Under the background of the increasing number of liver cirrhosis patients with metabolic abnormalities, how to optimize treatment is particularly important. The traditional treatment of diabetes at the stage of liver cirrhosis is limited to insulin intensive therapy, but the incidence of hypoglycemia is high, blood sugar fluctuates greatly, and multiple injections are required. Research shows that insulin therapy has an increased overall mortality compared with non insulin therapy. We used metformin,Ryzodeg and an oral DDP IV enzyme inhibitor as the core combination according to the special pathological mechanism of elevated blood glucose in liver cirrhosis . After preliminary experiments, we found that the program was stable and was not easy to have hypoglycemia, and there was no traditional risk of lactic acid poisoning caused by metformin. We designed an open randomized controlled clinical study, Compared with the traditional insulin intensive treatment scheme, this new combination scheme was compared whether it could improve the blood glucose level, the incidence of hypoglycemia and lactic acid level, the incidence of cirrhosis complications, and the long-term survival rate of liver disease. This study is helpful to optimize the hypoglycemic treatment of cirrhosis with diabetes, and improve the blood glucose and long-term prognosis, The positive evidence of this study contributes to the consensus or guidelines for the treatment of cirrhosis with diabetes.

Conditions

Liver Cirrhosis; Diabetes

Keywords

Liver cirrhosis; diabetes; time in range; insulin intensive therapy; new combination therapy

Outcome Measures

Primary Outcomes (3)

• time in range

  time in range

  two weeks

• Blood lactic acid level

  Blood lactic acid level

  two week

• Compound adverse events

  includetimes of hypolgycemia attack，severe hypoglycemia attack and serum lactic acid more than 2.2 mmol/L, complications of liver cirrhosis within two week

  two week

Secondary Outcomes (9)

• mean blood glucose

  two weeks

• Time above range

  two weeks

• Time below range

  two weeks

• Blood lactic acid

  two weeks

• Glycated Albumin

  two week

Study Arms (2)

group with new combination therapy

EXPERIMENTAL

The hypoglycemic scheme of the experimental group was that the initial dose of Insulin Degludec and Insulin Aspart was 0.3U/kg multiplied by the patient's weight, plus 5 mg of linagliptin and 0.5 g of metformin three times a day.

Drug: Insulin Degludec and Insulin Aspart

group with intensive insulin therapy

ACTIVE COMPARATOR

group was treated with intensive insulin therapy.The initial total amount of insulin is 0.5U/kg, of which 40% is basal insulin and 20% is aspart insulin before three meals

Drug: Insulin Degludec and Insulin Aspart

Interventions

Insulin Degludec and Insulin Aspart DRUG

The hypoglycemic scheme of the experimental group was that the initial dose of Insulin Degludec and Insulin Aspart was 0.3U/kg multiplied by the patient's weight, plus 5 mg of linagliptin and 0.5 g of metformin three times a day. The control group was treated with traditional four needle insulin.

Also known as: metformin, linagliptin

group with intensive insulin therapy; group with new combination therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Liver cirrhosis
• Age 18-70 years
• Patients with elevated blood sugar who meet the diabetes standard or have been treated with hypoglycemic drugs
• random finger or venous serum blood glucose more than 14 mmol/L

You may not qualify if:

• Those unwilling to participate or unable to cooperate;
• Child-pugh score is greater than 12;
• Glomerular filtration rate\<60ml/min/1.73m2;
• Patients with cardiac insufficiency;
• Patients with asymptomatic hypoglycemia;
• Pregnant patients were excluded;
• Patients with advanced liver cancer;
• Blood pressure is less than 90/60mmHg;
• Chronic liver disease plus acute or subacute liver failure;
• Patients with drug induced blood glucose disorder, such as glucocorticoids, contraceptives, etc;
• fingertip oxygen saturation less than 95% without oxygen inhalation;
• Autoimmune liver cirrhosis is currently taking hormone.
• Type 1 diabetes.
• Pancreatogenic diabetes, such as primary hemochromatosis, hepatolenticular degeneration, alcoholic pancreatitis, autoimmune diseases involving the pancreas, etc.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Xiaolong Zhao

Shanghai, Shanghai Municipality, 200041, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Diabetes Mellitus

Interventions

insulin degludec, insulin aspart drug combination; Metformin; Linagliptin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Study Officials

• Xiaolong Zhao, PhD

  Shanghai Public Health Clinical Center

  STUDY CHAIR

Central Study Contacts

Xiaolong Zhao, PhD

CONTACT

13501827230; xiaolongzhao@163.com

Duoduo Qu, Master

CONTACT

19852812469; quduoduonju@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: November 6, 2022
• First Posted: December 7, 2022
• Study Start: October 1, 2022
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: December 7, 2022

Record last verified: 2022-11

Locations

CN (1)